The final deadline for implementation of Schedule M in the India's pharmaceutical industry is set for December 2004 after many postponements in the past. It is quite unlikely that the Union health ministry would grant any more extension beyond December. And that is understandable. Pharmaceutical companies, if they are genuinely interested in modernizing their plants, they should have made up their minds by now. As per the figures collected by the Mashelkar Committee from the state drug control authorities, there are only 5748 drug manufacturing units in the country. Out of that 1,000 and odd units may have complied with GMP norms. A large number of remaining pharmaceutical units are too small and are not having adequate financial strength to modernize their plants. Certainly most of them need financial assistance to implement GMP and are looking forward to soft loans and subsidies. At the same time, there are a good number of units, which are not willing to modernize their units. There should be no sympathy in such cases and they should be shut down. A significant outcome of the government decision to implement GMP in this industry, however, is that undesirable growth in the number of drug units has come to a halt. Most of the state drug authorities have stopped issuing new drug manufacturing licenses without first establishing facilities specified in Schedule M of the Drugs and Cosmetics Act.
Adoption of international standards in drug manufacturing is extremely crucial for the Indian pharmaceutical industry considering its growing exposure to developed markets. Almost one third of India's pharmaceutical production is being currently exported to various regulated markets. Many top Indian companies are already exporting more than 50 percent of their total production to these developed countries since last three years. A good part of these exports is generics. The international business of Indian pharma companies is only going to expand dramatically in the years to come considering the intense efforts they are making in these markets. Therefore a uniform minimum standard in drug manufacturing for this industry is more than a necessity. The move by the Union ministry of Small Scale Industries to make the Credit Linked Capital Subsidy Scheme for technology upgradation of SSI units is very encouraging. The ministry has proposed to increase the subsidy limit for SSIs from 12 percent to 20 percent and the maximum limit for loan from Rs.40 lakhs to Rs.1 crore .The ministry has recently notified a revised list of technologies, which could be adopted by the drug units under the scheme. The revised CLCSS should be taken as an opportunity by the SSIs and should comply with GMP norms with any more delay. Now, the organizations representing the SSIs have a responsibility to come forward and motivate their members to comply with the Schedule M in the national interest.